Updated Research-Related Injury Language Required by August 1, 2024

For research involving greater than minimal risk, participants must be informed about options available in case they get injured. The University of Utah IRB mandates specific language for addressing research-related injuries.

To make it easier to understand (aiming at an 8-9th grade reading level instead of 10-12th), we’ve revised this injury language. Researchers will be required to use this updated language in new studies submitted on or after August 1, 2024.

If a study was approved before this update, study teams are not required to change the injury language at continuing review or via amendment. However, study teams may choose to update the language voluntarily, as the changes are intended to simplify terms and shorten the paragraphs. The previously approved language remains valid.

Expired Study Continuation Requests Can Now be Submitted in ERICA

When a study’s IRB approval period expires, all study procedures must stop. Study procedures may not begin again until a new approval is in place. There is no grace period extending the conduct of the research beyond the expiration date of IRB approval.

However, the IRB can grant a limited expired study continuation in cases where there is evidence that stopping certain procedures during the period of expiration could harm the safety and/or well-being of the currently enrolled participants.

The process has now been streamlined and is built into the ERICA system rather than filling out a request form and emailing it to the IRB.